POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes For medicinal products, Poland does not provide a separate “national fast-track” marketing authorisation route. Accelerated pathways are primarily available at EU level (in particular, within the centralised pro- cedure). Under the EU framework, eligible medicines may benefit from accelerated assessment (typically 150 evaluation days instead of 210) and, in certain cases (unmet medical need/public health emergen- cies), from conditional marketing authorisation with specific post-authorisation obligations. The regulations concerning the placing on the market of medical devices are contained in the IVDR/MDR. No accelerated procedures are provided for at the national level but the President of the URPL, acting as the competent authority within the meaning of Arti- cle 59 (1) of the MDR/Article 54 (1) of the IVDR, may issue a decision authorising the placing on the market or putting into service in the territory of the country of a specific medical device in respect of which no conformity assessment has been carried out, where the use of that device is in the interest of public health Poland participates in EU authorisation pathways based on recognition of another member state’s sci- entific assessment, in particular the mutual recogni- tion procedure (MRP) and the decentralised procedure (DCP), which are grounded in reliance on an assess- ment led by a reference member state. Authorisations from non-EU jurisdictions (eg, FDA approvals) do not, as such, trigger an expedited Polish reliance authori- sation pathway outside these EU procedures. Regarding medical devices, there is no need or space for regulatory reliance laws on a local level. Poland is a member of the EU, so the regulatory framework for medical devices is mostly aligned with EU law. Medical devices are placed on the Polish market and across the entire EU based on CE marking obtained via conformity assessment. The President of the URPL (the Polish competent authority) does not per- form any pre-market assessment based on foreign or patient safety or health. 4.2 Regulatory Reliance
(non-EU) authorisations. The URPL’s role is limited to market surveillance, registration of certain economic operators (eg, distributors, custom-made manufactur- ers), notifications and enforcement. While mutual recognition agreements may exist in conformity assessment areas, under the MDR/IVDR there is no practical mechanism whereby third-country authorisations replace the EU conformity assessment/ CE marking. By way of example, the EU–Switzerland MRA chapter on medical devices has not been updat- ed for the MDR/IVDR, so Switzerland has been treated as a third country for medical devices since May 2021 (and for IVDs since May 2022). 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Undertaking the business of manufacturing pharma- ceuticals requires a manufacturer’s licence, issued by the Chief Pharmaceutical Inspector. The manufac- turing of a medicinal product is any activity leading to the creation of a medicinal product, including the purchase and receipt at the manufacturing site by the manufacturer of materials used for production and their release for subsequent manufacturing stages, including packaging or repackaging and storage and distribution of manufactured medicinal products cov- ered by the application for a manufacturing authori- sation, as well as control activities related to these activities. An applicant for a manufacturer’s licence should sub- mit an application containing, among other things, the type and pharmaceutical form of the medicinal prod- uct, the place of manufacture of the medicinal prod- uct, and a determination of the scope of manufacture of the medicinal product. The model application is specified in the Regulation of the Minister of Health of 29 April 2019 on the model application for granting or amending the authorisation to manufacture or import medicinal products. The permit is issued for an indefinite period of time.
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